Educational Program

MDR 745/2017 and IVDR 746/2017

Good Distribution Practices for Medical Devices – New Regulations Requirements

MDR 745 2017

Professionals in Research and Development, Regulatory, Quality Management, Technical, Clinical, Inspectors, Consultants from companies or organizations such as:

  • Medical device supply chain (designers, manufacturers, importers, maintainers)
  • Healthcare providers (hospitals, clinics, medical practices, diagnostic laboratories)
  • Companies involved in medical devices as a secondary activity (pharmaceutical, cosmetic, biocidal, etc.)
  • Consultants, agencies, inspectors, service providers, health innovation organizations (such as research centers and university laboratories dealing with health, start-up and spin-off companies, federations, incubators and reference organizations with action in health)
Information

The main objective of the program is to inform and raise awareness of all professionals in the broader healthcare sector regarding the changes brought about by the new European Medical Device Regulations MDR 745/2017 and IVDR 746/2017, in the Circulation of Medical Devices (from Import into the Community and Circulation, to Supply and Disposal to the user).

Participants will recognize the changes in the legislation and identify the points of the Circulation processes that are affected by them.

An explanation is given of the Compliance of Medical Devices in the context of the New Regulations and the Economic Operators involved in the supply chain.

In addition, practical references are made to the methodology for approaching compliance (and the documentation it requires – Certificates, Declarations of Conformity and others) as appropriate.

It is estimated that this training is essential for every professional in the sector and directly contributes to the difficulty of managing the new requirements, to achieving a smooth transition of organizations and individuals to the new Regulations and to the emphasis that is beneficial to give to the spirit and substance of the implemented changes.

To inquire about the cost of the courses contact us. BQC adjusts its pricing policy for the unemployed and for students. Every second participation from the same company will have a 10% discount.

The teaching methods used include lectures, practical exercises and group collaboration.

In this context, participants are asked to complete group and individual exercises and assignments, as well as Role playing exercises, which aim to develop their skills (time management, team spirit, collaboration).

At the end, an evaluation test and a satisfaction questionnaire are distributed to participants to evaluate the results of their training and the achievement of its objectives.

  • REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, (application date: 26 May 2021)
  • REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices (application date: 26 May 2022)
  • Approved MDCG Directives (relating to Marketing, as well as references to relevant MEDDEVs, Consensus statements and Informative documents / Factsheets
  • Substitution (in force as applicable in cases of product categories in a transitional period and other relevant references):
  • Directive 93/42/EEC on medical devices: Harmonization of National Legislation: DY8d/G.P.oik130648/Government Gazette 2198B/02-10-2009
  • Directive 90/385/EEC on Active Implantable Medical Devices: Harmonization of National Legislation: DY8d/G.P.oik130644/Government Gazette 2197B/02-10-2009
  • Directive 98/79/EC – 27/10/98 (FOR IN VITRO DIAGNOSTIC MEDICAL PRODUCTS): Harmonization: DY8d/oik3607/892/Government Gazette 1060B’/10-8-01
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Ημερομηνία
Πρόγραμμα
Συμμετοχή
04/04/2025
Good Distribution Practices for Medical Devices Requirements of New Regulations MDR 745/2017 and IVDR 746/2017

Education Methodology

The teaching methods used include lectures, practical training and group work.

In this context, participants are invited to carry out group and individual exercises and tasks, as well as role playing exercises, aimed at developing their skills (time management, team spirit, cooperation).

At the end, an evaluation test and a satisfaction questionnaire are distributed to the participants in order to evaluate the results of their training and the achievement of its objectives.

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